US FDA approves J&J’s oral psoriasis pill

By Sriparna Roy

March 18 (Reuters) – The U.S. Food and Drug Administration has approved Johnson & Johnson’s oral pill for psoriasis, the company said on Wednesday, paving the way for a more convenient treatment option for patients with the chronic autoimmune condition that causes itchy, scaly, and inflamed patches of skin.

The health regulator approved the drug for moderate-to-severe plaque psoriasis in adults and children 12 years of age and older who weigh at least 40 kg.

The company did not respond to a Reuters request for comment on pricing and availability.

The first-of-its-kind oral drug, branded as Icotyde, will help the drugmaker expand into the psoriasis market and compete with treatments such as Bristol Myers Squibb’s Sotyktu and AbbVie’s Skyrizi.

Wall Street analysts have said Icotyde has “blockbuster potential” as a safe and effective oral, and that the once-daily medication could capture significant market share from injectables like Skyrizi and J&J’s own Tremfya.

“The key now will be Icotyde’s commercial uptake, which we think will be quite rapid given its clinical profile as a potential best oral option for patients with psoriasis,” said Guggenheim analyst Vamil Divan.

Divan estimates that Icotyde could generate more than $8 billion in annual peak sales.

The drug has shown superior skin clearance compared with Bristol’s Sotyktu in two late-stage, head-to-head trials.

Patients have been looking for complete skin clearance, a favorable safety profile, and the simplicity of a once-a-day pill, David Lee, J&J’s global head of immunology, told Reuters ahead of the decision.

“We see Icotyde as becoming the first-line systemic therapy for psoriasis patients,” said Lee.

J&J’s oral pill is designed to block a protein, IL-23, involved in inflammatory responses. The oral drug is developed in partnership with Protagonist Therapeutics.

J&J is also studying the drug, chemically known as icotrokinra, for ulcerative colitis, psoriatic arthritis and Crohn’s disease.

The company expects Icotyde to exceed $5 billion in peak annual sales across indications.

(Reporting by Sriparna Roy in Bengaluru; Editing by Alan Barona, Shinjini Ganguli and Devika Syamnath)